Multicenter Clinical Study on Noninvasive Assessment of Hepatic Steatosis and Fibrosis Using Visual Transient Elastography

Phase

N/A

Condition

N/A

Treatment

Visual Transient Elastography (ViTE) Examination

Clinical Study ID

NCT07128108

Hepatus-V1

Ages 18-65
All Genders

Study Summary

Using liver biopsy as the gold standard, this study will conduct visual transient elastography (ViTE) examinations using Mindray Hepatus 9 ultrasound diagnostic system in patients with liver injury to evaluate the diagnostic efficacy of Liver Steatosis Analysis (LiSA) and ViTE for grading hepatic steatosis and fibrosis, and establish corresponding diagnostic thresholds.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Be aged 18-65 years.
Documented liver injury of any etiology with a liver biopsy performed within thepast 2 weeks.
Willing to undergo Visual Transient Elastography (ViTE) examination using MindrayHepatus 9 Ultrasound System and capable of providing written informed consent.

Exclusion

Exclusion Criteria:

Acute viral hepatitis.
Right heart failure with either:Serum transaminases >5× upper limit of normal (ULN),Total bilirubin >85.5 μmol/L.
History of hepatocellular carcinoma (HCC).
Pregnancy.
Patients with implantable medical devices.

Study Design